TerminatedNot Applicable

Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty

Stopped: the clinical data collected to date are sufficient for regulatory requirements

France2,146 participantsStarted 2011-12-15

Plain-language summary

The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult patients older than 18 years old.
✓. Patients who have undergone routine preoperative clinical evaluations prior to their Total Knee Replacement surgery and implanted with one of the following prostheses from the HLS range: HLS-1, HLS-2, HLS Evolution and HLS Noetos between their first date of use in 1987 and their last date of use as normal practice at the participating site in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.
✓. Patients who have been informed about their participation into an observational study.
✓. Adult patients older than 18 years old.
✓. Patients who have undergone routine preoperative clinical evaluations and received a TKR or are suitable candidates for a TKR with a fixed or mobile postero-stabilized HLS KneeTec prosthesis (cementless, cemented or hybrid combination) for the treatment of a primary or secondary knee osteoarthritis and inflammatory disease such as rheumatoid arthritis in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.
✓. Patients who are willing and able to complete the scheduled FU visits.
✓. Patients who have been informed about their participation into an observational registry study

Evaluation of long-term survivorship of total knee replacement surgeries with HLS devices

Timeframe: 10-year

NCT IDNCT04727060

SponsorCorin

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-11

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult patients older than 18 years old.
✓. Patients who have undergone routine preoperative clinical evaluations prior to their Total Knee Replacement surgery and implanted with one of the following prostheses from the HLS range: HLS-1, HLS-2, HLS Evolution and HLS Noetos between their first date of use in 1987 and their last date of use as normal practice at the participating site in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.
✓. Patients who have been informed about their participation into an observational study.
✓. Adult patients older than 18 years old.
✓. Patients who have undergone routine preoperative clinical evaluations and received a TKR or are suitable candidates for a TKR with a fixed or mobile postero-stabilized HLS KneeTec prosthesis (cementless, cemented or hybrid combination) for the treatment of a primary or secondary knee osteoarthritis and inflammatory disease such as rheumatoid arthritis in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.
✓. Patients who are willing and able to complete the scheduled FU visits.
✓. Patients who have been informed about their participation into an observational registry study